Abortion, Recurrent Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of the EVE- Skin-Test Panel in Detecting Sensitivity to Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
The EVE- technology is intended for determination of intolerance or sensitivity to female
sex hormones among women with hormone-related conditions and for further treatment by
desensitization procedure inducing a tolerance to the hormones the women are sensitive to.
This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to
detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy
Loss (URPL) and in Control parous, healthy women.
The Skin Test Panel includes four female hormones and three control solutions.
Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the
subject's menstrual cycle. The skin reactions are examined by physician for erythema and
wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following
month.
Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy
loss (UPRL) and healthy groups.
Following achievement of the significant differences between both groups the immune profile
of the healthy and UPRL subjects will be investigated.
n/a
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05190796 -
Platelet Indices and Recurrent Pregnancy Loss
|